On July 26, 2018, the FDA held a public meeting to discuss issues related to the agency’s comprehensive multi-year Nutrition Innovation Strategy. This public meeting and comment period follows FDA Commissioner Dr. Scott Gottlieb’s unveiling of the Nutrition Innovation Strategy in a policy address on March 29, 2018 as a way to help Americans improve their nutrition as a step towards reducing chronic disease. This post provides a high-level summary of the issues that were raised at the public meeting.
A California appeals court has reversed a trial court decision that would require businesses to post Proposition 65 cancer warnings on certain breakfast cereals for acrylamide. The court ruled that a Proposition 65 warning for acrylamide on these cereals would pose an obstacle to the federal scheme, and therefore is preempted by federal law. To support the ruling, the panel of appeals court judges referenced the advisory letters issued by the FDA to the California regulators and Attorney General with “persuasive reasoning why Proposition 65 acrylamide warnings on whole grain cereals would mislead consumers and lead to health detriments.” We do not know if the decision will be appealed to the California Supreme Court.
The U.S. Appeals Court for the 9th Circuit issued a favorable decision earlier this year interpreting the California “made in the USA” statute. In a March 2018 unpublished opinion, the court affirmed the dismissal of lawsuits filed over the labeling of dog food and treats as “made in the USA” when they contained tapioca starch, an ingredient derived from a plant not commercially grown in the U.S. The appeals court decision confirms that a plaintiff cannot bring a lawsuit to challenge a “made in the USA” claim under the old, stricter version of the California “made in the USA” statute. Instead, such claims would be governed by the more permissive version of the statute that permits a made in the USA claim when a product contains certain small amounts of foreign-sourced ingredients consistent with one of two exemptions. The case did not address how the claim should be viewed under the Federal Trade Commission (FTC) standard for U.S. origin claims.
The Food and Drug Administration (FDA) is proposing to revise the type size requirements for front-of-pack (FOP) calorie declarations that are used to comply with the vending machine calorie labeling requirements. The proposed rule would require such calorie declarations to be at least 150% the size of the net quantity of contents statement (i.e., 1.5 x the size of the net weight). This proposed change was prompted by industry concerns that the current type size requirement for FOP calorie declarations – of at least 50% of the size of the largest printed matter on the label – is impractical, needlessly burdensome, and would disrupt existing voluntary industry front-of-pack nutrition labeling programs. The existing programs require FOP calorie declarations to appear in a type size ranging from 100 to 150% of the size of the net quantity of contents statement.
On June 15, 2018, the Office of the United States Trade Representative (USTR) released a list of products imported from China that will be subject to additional tariffs as part of the United States response to China’s alleged unfair trade practices related to technology and intellectual property. The tariffs will pose an additional duty of 25 percent on approximately $50 billion worth of Chinese imports containing industrially significant technologies. The announcement follows a Section 301 investigation in which the USTR found that China’s acts, policies and practices related to technology transfer, intellectual property, and innovation are unreasonable and discriminatory, and burden United States commerce. United States Customs and Border Protection will begin to collect the additional duties from China on July 6, 2018 on an initial list of products affecting $36 billion in imports.
On Friday, June 15th, the California Office of Environmental Health Hazard Assessment (OEHHA) announced a proposed regulation clarifying that exposures to Proposition 65 chemicals in coffee do not pose a significant cancer risk. The proposal follows a recent California Superior Court ruling that the coffee industry failed to meet its burden of proof on its alternative significant risk level (ASRL) affirmative defense to its failure to warn of the presence of acrylamide in coffee under Proposition 65. The proposed regulation is significant as, if adopted, it would effectively exempt coffee products from Proposition 65 carcinogen warning requirements.
The Food and Drug Administration (FDA) announced a public meeting and comment period on the agency’s comprehensive multi-year Nutrition Innovation Strategy. This public meeting and comment period follows FDA Commissioner Scott Gottlieb’s unveiling of the Nutrition Innovation Strategy in a policy address on March 29, 2018 as a way to help Americans improve their nutrition as a step towards reducing chronic disease. This post details the proposed topics to be discussed at the meeting, as well as the logistics for the meeting and comment period.
The U.S. Food and Drug Administration (FDA) has released the first of three installments of its long awaited Draft Guidance to support compliance with the Mitigation Strategies to Protect Food Against Intentional Adulteration (IA) rule. Under the IA rule, the last of the major FDA Food Safety Modernization Act (FSMA) rules to be released, food facilities must develop and implement a food defense plan that identifies their significant vulnerabilities and mitigation strategies to address those vulnerabilities, and they must take steps to ensure those mitigation strategies are working. This first installment includes the first four chapters of the Draft Guidance, which provide FDA’s recommendations on how to develop a food defense plan, including one particular method for conducting a vulnerability assessment to identify significant vulnerabilities and actionable process steps, developing mitigation strategies for actionable process steps, and monitoring mitigation strategies. It also contains templates for various components of a food defense plan.
The Food and Drug Administration (FDA) has issued a guidance document that identifies eight ingredients that the agency has determined meet the regulatory definition of “dietary fiber.” Specifically, FDA has recognized the following ingredients as meeting the dietary fiber definition: (1) mixed plant cell wall fibers; (2) arabinoxylan; (3) alginate; (4) inulin and inulin-type fructans; (5) high amylose starch (resistant starch 2); (6) galactooligosaccharide; (7) polydextrose; and (8) resistant maltodextrin/dextrin. In this guidance document, FDA also announced that it intends to extend enforcement discretion regarding the declaration of these eight isolated or synthetic nondigestible carbohydrates (NDCs) as a dietary fiber on Nutrition Facts and Supplement Facts labels pending completion of a formal rulemaking to revise the dietary fiber regulation to reflect these ingredients. In addition to the guidance document, FDA has also published a review of the scientific evidence on the physiological effects of these NDCs, and has issued responses to several citizen petitions requesting that certain NDCs be added to the “dietary fiber” definition.
This post provides a brief overview of FDA’s dietary fiber definition, and summarizes the key aspects of the guidance related to FDA’s determination that these eight ingredients meet the dietary fiber definition.
The U.S. Department of Agriculture’s (USDA’s) Food Safety and Inspection Service (FSIS) recently released a guidance document to help companies determine whether their operations are exempt from the inspection requirements of the Federal Meat Inspection Act (FMIA). This guidance marks FSIS’s first significant attempt to articulate policy addressing the applicability of its retailer and restaurant exemptions to newer food distribution models, such as online retailers and home delivered meal services. In particular, the guidance confirms that online-only grocery stores and home delivery meal kit services are eligible for the retailer exemption from FSIS inspection.
This post focuses on new aspects of FSIS’s guidance that apply to operations such as online grocery stores, online markets, meal kit delivery services, and restaurants, although the guidance addresses other exemptions including custom slaughter operations.